- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Bring issues with the reconciliation to the attention of the supervisor. Distribute key study documents to the CRO and vendors as appropriate.Upload DS country and ... study level documents to the TMFConfirm Essential Document Listing...career development plan.Assist in planning and execution of clinical studies , under the close supervision of a Manager (or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good Clinical Practices ... and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager, Study Associates, under the guidance of the Associate Director, will supervise a ... group of Study Associates (SAs) or Senior SAs who assist in...assist in planning and in the execution of clinical studies in adherence to the protocol, Good Clinical Practices… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops SAE ... Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Statistical Programmer, Study Data Tabulation Model (SDTM), provides oversight and creation of the Study Data Tabulation Mode (SDTM) ... predominantly includes creation and validation of Case Report Tabulation (SDTM) study data deliverables Study Data Tabulation Model (SDTM) dataset,… more
- Merck & Co. (North Wales, PA)
- …Job Responsibilities May have specific operational responsibilities for a single study or across multiple studies (eg, operational deliverables, clinical ... & ancillary supplies planning/tracking, lab specimen tracking, status update reports, study closeout activities).May be responsible for tracking study timelines… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in adherence to ... interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and...the timeline, budget and objectives set forth by the Study team.The Clinical Study Manager role is… more
- Merck & Co. (Rahway, NJ)
- …include the following: - May have specific operational responsibilities for a single study or across multiple studies (eg, operational deliverables, clinical & ... execution of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of the GCTO organization focuses on the planning, execution… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leadership, Direction, and Strategy:Establishes Data Management strategy at the project and/or study level for a smaller number of projects/ studies Proactively ... identifies and manages risks at the project and/or study level for a smaller number of projects/ studies... study level for a smaller number of projects/ studies Project Management:Plans and directs the conduct of Data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the internal and external network. Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities. Provides medical and ... scientific expertise to cross-functional DSI colleaguesResponsibilities Medical Monitoring: For studies in which Medical Monitoring activities are conducted in-house:Provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PIs to plan study and monitor completionStudy outputs: For Phase 2 studies : Drafts responses to IRBs and HA, Collaborates with TMCP to ensure appropriate ... Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major scientific/medical contributor; For large or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of high quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle. The CS lead will also ... contribute to the program study strategy, planning, execution and reporting outputs. CS lead...Global (Oncology) Clinical Science Strategy and delivery of clinical studies for one or several oncology assets:- Lead and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical outputs ... supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regarding quality, time, and cost.Establishes medical coding strategy at the project and/or study level for a larger number of projects/ studies with greater ... across programs and organizationProactively identifies and manages risks at the project and/or study level for a larger number of projects/ studies with greater… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies , lead projects, and/or ensure proper ... our Discovery and Research programs for development of early clinical studies . Provides senior level clinical representation at meetings with health authorities;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design, ... study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary Position leads statistical support for low to medium complexity studies including contributing to development of optimal study design, ... report (CSR): Executes statistical activities for low to medium complexity studies including study design, protocol development, CRF review, SAP development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …site scientific engagement, and HA responses. Interactions with the internal clinical study physicians and physician scientists as well as external investigators is ... clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle is...the Global Clinical Science Strategy and delivery of clinical studies in late stage development. Lead and manage the… more
- Merck & Co. (Rahway, NJ)
- …Clinical Scientist and study team with the scientific conduct of clinical studies . In this position, you will have the opportunity to develop your leadership, ... the following: - Responsible for specific clinical/scientific activities on a single study or across multiple studies (eg, medical monitoring, lab specimen… more
